NCT01693562 · ADVERSE EVENTS

Adverse events

A Phase 1/2 Study to Evaluate MEDI4736 · Source last updated 2021-05-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	1 / 4	3 / 4	4 / 4
Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	2 / 4	4 / 4	2 / 4
Escalation Cohort (MEDI4736 1 mg/kg Q2W) Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	1 / 3	3 / 3	0 / 3
Escalation Cohort (MEDI4736 3 mg/kg Q2W) Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	1 / 3	3 / 3	3 / 3
Escalation Cohort (MEDI4736 10 mg/kg Q2W) Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	3 / 6	6 / 6	6 / 6
Escalation Cohort (MEDI4736 15 mg/kg Q3W) Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	3 / 7	7 / 7	4 / 7
Exploration Durvalumab 20 mg/kg (Q4W) Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	13 / 21	20 / 21	17 / 21
Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	30 / 62	61 / 62	42 / 62
Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	16 / 22	22 / 22	17 / 22
Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	163 / 304	292 / 304	208 / 304
Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	24 / 40	40 / 40	30 / 40
Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	7 / 21	19 / 21	8 / 21
Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) Participants with uveal melanoma (UM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	12 / 24	22 / 24	19 / 24
Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	26 / 51	50 / 51	42 / 51
Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	20 / 40	39 / 40	23 / 40
Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	25 / 31	31 / 31	23 / 31
Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	117 / 201	194 / 201	128 / 201
Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	9 / 20	18 / 20	16 / 20
Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) Participants with ovarian cancer (OC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	26 / 47	46 / 47	36 / 47
Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	7 / 20	20 / 20	16 / 20
Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	14 / 21	17 / 21	17 / 21
Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	31 / 62	57 / 62	35 / 62
Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W) Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.	7 / 10	10 / 10	7 / 10

Group identifiers: EG000: Escalation Cohort (MEDI4736 0.1 mg/kg Q2W) · EG001: Escalation Cohort (MEDI4736 0.3 mg/kg Q2W) · EG002: Escalation Cohort (MEDI4736 1 mg/kg Q2W) · EG003: Escalation Cohort (MEDI4736 3 mg/kg Q2W) · EG004: Escalation Cohort (MEDI4736 10 mg/kg Q2W) · EG005: Escalation Cohort (MEDI4736 15 mg/kg Q3W) · EG006: Exploration Durvalumab 20 mg/kg (Q4W) · EG007: Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W) · EG008: Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W) · EG009: Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W) · EG010: Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W) · EG011: Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W) · EG012: Expansion UM Cohort (MEDI4736 10 mg/kg Q2W) · EG013: Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W) · EG014: Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W) · EG015: Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W) · EG016: Expansion UC Cohort (MEDI4736 10 mg/kg Q2W) · EG017: Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W) · EG018: Expansion OC Cohort (MEDI4736 10 mg/kg Q2W) · EG019: Expansion STS Cohort (MEDI4736 10 mg/kg Q2W) · EG020: Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W) · EG021: Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W) · EG022: Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
1
num At Risk
22
num Events
1
group Id
EG009
num Affected
1
num At Risk
304
num Events
1
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
1
num At Risk
304
num Events
2
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Immune thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
1
num At Risk
62
num Events
1
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
1
num At Risk
304
num Events
1
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
1
num At Risk
304
num Events
1
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
1
num At Risk
304
num Events
2
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
21
num Events
1
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
1
num At Risk
62
num Events
1
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Thrombocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
21
num Events
1
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
3
num At Risk
304
num Events
3
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
3
num At Risk
304
num Events
5
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Atrial flutter

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
10
num At Risk
62
num Events
11
group Id
EG008
num Affected
5
num At Risk
22
num Events
7
group Id
EG009
num Affected
47
num At Risk
304
num Events
74
group Id
EG010
num Affected
5
num At Risk
40
num Events
6
group Id
EG011
num Affected
3
num At Risk
21
num Events
12
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
3
num At Risk
304
num Events
4
group Id
EG010
num Affected
2
num At Risk
40
num Events
3
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
2
num At Risk
304
num Events
8
group Id
EG010
num Affected
1
num At Risk
40
num Events
3
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Splenomegaly
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
8
num At Risk
304
num Events
12
group Id
EG010
num Affected
2
num At Risk
40
num Events
7
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
1
num At Risk
62
num Events
1
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
5
num At Risk
304
num Events
6
group Id
EG010
num Affected
1
num At Risk
40
num Events
3
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
1
num At Risk
304
num Events
1
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Extrasystoles
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
6
num At Risk
304
num Events
7
group Id
EG010
num Affected
2
num At Risk
40
num Events
2
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
2
num At Risk
62
num Events
2
group Id
EG008
num Affected
1
num At Risk
22
num Events
1
group Id
EG009
num Affected
2
num At Risk
304
num Events
3
group Id
EG010
num Affected
1
num At Risk
40
num Events
1
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Eustachian tube dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
1
num At Risk
62
num Events
1
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Otorrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
21
num Events
1
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
2
num At Risk
22
num Events
2
group Id
EG009
num Affected
12
num At Risk
304
num Events
19
group Id
EG010
num Affected
2
num At Risk
40
num Events
2
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Hyperthyroidism

Complete source fields

event Groups

deaths Num Affected
4
deaths Num At Risk
4
description
Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
EG000
other Num Affected
3
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)
deaths Num Affected
2
deaths Num At Risk
4
description
Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
EG001
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)
deaths Num Affected
0
deaths Num At Risk
3
description
Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
EG002
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Escalation Cohort (MEDI4736 1 mg/kg Q2W)
deaths Num Affected
3
deaths Num At Risk
3
description
Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
EG003
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Escalation Cohort (MEDI4736 3 mg/kg Q2W)
deaths Num Affected
6
deaths Num At Risk
6
description
Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
EG004
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Escalation Cohort (MEDI4736 10 mg/kg Q2W)
deaths Num Affected
4
deaths Num At Risk
7
description
Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
EG005
other Num Affected
7
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Escalation Cohort (MEDI4736 15 mg/kg Q3W)
deaths Num Affected
17
deaths Num At Risk
21
description
Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
EG006
other Num Affected
20
other Num At Risk
21
serious Num Affected
13
serious Num At Risk
21
title
Exploration Durvalumab 20 mg/kg (Q4W)
deaths Num Affected
42
deaths Num At Risk
62
description
Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
EG007
other Num Affected
61
other Num At Risk
62
serious Num Affected
30
serious Num At Risk
62
title
Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)
deaths Num Affected
17
deaths Num At Risk
22
description
Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
EG008
other Num Affected
22
other Num At Risk
22
serious Num Affected
16
serious Num At Risk
22
title
Expansion Non-SCCHN HPV Positive Cohort (MEDI4736 10 mg/kg Q2W)
deaths Num Affected
208
deaths Num At Risk
304
description
Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
EG009
other Num Affected
292
other Num At Risk
304
serious Num Affected
163
serious Num At Risk
304
title
Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)
deaths Num Affected
30
deaths Num At Risk
40
description
Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
EG010
other Num Affected
40
other Num At Risk
40
serious Num Affected
24
serious Num At Risk
40
title
Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)
deaths Num Affected
8
deaths Num At Risk
21
description
Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.
id
EG011
other Num Affected
19
other Num At Risk
21
serious Num Affected
7
serious Num At Risk
21
title
Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
1
num At Risk
4
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
10
num At Risk
62
num Events
11
group Id
EG008
num Affected
5
num At Risk
22
num Events
7
group Id
EG009
num Affected
47
num At Risk
304
num Events
74
group Id
EG010
num Affected
5
num At Risk
40
num Events
6
group Id
EG011
num Affected
3
num At Risk
21
num Events
12
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
3
num At Risk
304
num Events
4
group Id
EG010
num Affected
2
num At Risk
40
num Events
3
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
2
num At Risk
304
num Events
8
group Id
EG010
num Affected
1
num At Risk
40
num Events
3
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Splenomegaly
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
8
num At Risk
304
num Events
12
group Id
EG010
num Affected
2
num At Risk
40
num Events
7
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
1
num At Risk
62
num Events
1
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
5
num At Risk
304
num Events
6
group Id
EG010
num Affected
1
num At Risk
40
num Events
3
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
7
num Events
1
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
1
num At Risk
304
num Events
1
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Extrasystoles
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
6
num At Risk
304
num Events
7
group Id
EG010
num Affected
2
num At Risk
40
num Events
2
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
2
num At Risk
62
num Events
2
group Id
EG008
num Affected
1
num At Risk
22
num Events
1
group Id
EG009
num Affected
2
num At Risk
304
num Events
3
group Id
EG010
num Affected
1
num At Risk
40
num Events
1
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Eustachian tube dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
1
num At Risk
62
num Events
1
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Otorrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
21
num Events
1
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
2
num At Risk
22
num Events
2
group Id
EG009
num Affected
12
num At Risk
304
num Events
19
group Id
EG010
num Affected
2
num At Risk
40
num Events
2
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Hyperthyroidism

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
1
num At Risk
22
num Events
1
group Id
EG009
num Affected
1
num At Risk
304
num Events
1
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
1
num At Risk
304
num Events
2
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Immune thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
1
num At Risk
62
num Events
1
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
1
num At Risk
304
num Events
1
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
1
num At Risk
304
num Events
1
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
1
num At Risk
304
num Events
2
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
21
num Events
1
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
1
num At Risk
62
num Events
1
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Thrombocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
0
num At Risk
304
num Events
0
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
1
num At Risk
21
num Events
1
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
3
num At Risk
304
num Events
3
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.1
stats
group Id
EG000
num Affected
0
num At Risk
4
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
3
num Events
0
group Id
EG003
num Affected
0
num At Risk
3
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
7
num Events
0
group Id
EG006
num Affected
0
num At Risk
21
num Events
0
group Id
EG007
num Affected
0
num At Risk
62
num Events
0
group Id
EG008
num Affected
0
num At Risk
22
num Events
0
group Id
EG009
num Affected
3
num At Risk
304
num Events
5
group Id
EG010
num Affected
0
num At Risk
40
num Events
0
group Id
EG011
num Affected
0
num At Risk
21
num Events
0
term
Atrial flutter

time Frame

From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice